The U.S. Department of Health and Human Services launched SURPASS, a program intended to modernize how seamless trials are designed and run by leveraging predictive computational models and shared infrastructure. HHS described the approach as enabling earlier, real-time adaptation while reducing duplicated operational burdens. SURPASS will support digital twins for pre-launch testing of trial designs and an “inference engine” for on-demand analyses aimed at reducing reliance on large conventional control groups. The program also calls for agentic systems to automate trial start-up tasks, onboarding of treatment arms, and data preparation. Alongside the FDA’s expedited IND pilot concept, the moves signal a coordinated push to shorten timelines from discovery to first-in-human and to reduce friction in U.S. trial execution.